Hot Topics * Connect and Interact * Expert Presenters
Join hundreds of your colleagues from across the food and drug law community at this must-attend annual event to hear directly from leading regulators, both within and outside FDA, explore different viewpoints, shape policy, and advance understanding.
- Hear FDA’s 2017 strategic priorities directly from the Acting Commissioner, Chief Counsel, and leadership of FDA’s product Centers;
- Informative and thought-provoking plenary sessions;
- More than 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and economic issues;
- Learn from more than 100 well-known leaders in the federal government, industry, private bar, patient and consumer advocacy groups, consulting organizations, and academia; and
- A variety of opportunities to learn and network in both large and small groups.
Sessions Include
- Policies and Politics – Opportunities and Challenges for a New Administration
- 21st Century Cures Act: FDA Provisions and Implications
- Top 10 Cases in Food and Drug Law
- Networking Lunch with Facilitated Table Topic Discussions
Wednesday, May 3
5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel
Thursday, May 4
7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome
8:45–9:15 AM: FDA Keynote Address
9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration
10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions
Laboratory Developed Tests: What Now?
Key Regulatory Issues in Biosimilars
New Food Ingredients: US and EU Requirements and Strategic Considerations
The Animal Drug Compounding Debate
Tobacco Product Standards for Combustible Products: Nicotine and Beyond
11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions
Communicating Emerging Drug Therapies Prior to FDA Approval
Digital Health Technologies: A New FDA Regulatory Paradigm
Biologics Across the Globe: New Regulatory Challenges and Opportunities
Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
Patient-Centric Perspectives: Models for Patient Engagement
Criminal Prosecutions Under the Food, Drug & Cosmetic Act
12:30–2:00 PM: Luncheon
FDLI Distinguished Service and Leadership Awards
Award Recipients:
Keynote Speaker
2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Biologics Evaluation and Research (CBER)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
Center for Tobacco Products (CTP)
3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions
Legal Limits on Pharmacy Adherence and Discount Programs
Emerging Issues and Trends in Biologics Compliance and Enforcement
What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
Veterinary Products and FTC Enforcement
Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve
4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception
Friday, May 5
7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome
Service to FDLI Award
FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization
10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions
Challenges and Opportunities in Combination Medical Product Regulation
FDA’s Implementation of the 21st Century Cures Act
Regulation of Cannabis in FDA-Regulated Products
Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
CTP’s Compliance and Enforcement Initiatives Post-Deeming
12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions
FDA’s User Fee Program Reauthorization Update
Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
Defending Your Product: Crisis Management, Recalls, and Strategy
Economic Considerations for Biosimilar Litigation
2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment
Wednesday, May 3
5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel
Thursday, May 4
7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome
8:45–9:15 AM: FDA Keynote Address
9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration
10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions
New Food Ingredients: US and EU Requirements and Strategic Considerations
11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions
Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
Criminal Prosecutions Under the Food, Drug & Cosmetic Act
12:30–2:00 PM: Luncheon
FDLI Distinguished Service and Leadership Awards
Award Recipients:
Keynote Speaker
2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors
Center for Food Safety and Applied Nutrition (CFSAN)
3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions
What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception
Friday, May 5
7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome
Service to FDLI Award
FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization
10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions
Regulation of Cannabis in FDA-Regulated Products
Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions
Defending Your Product: Crisis Management, Recalls, and Strategy
2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment
Wednesday, May 3
5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel
Thursday, May 4
7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome
8:45–9:15 AM: FDA Keynote Address
9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration
10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions
Laboratory Developed Tests: What Now?
Key Regulatory Issues in Biosimilars
The Animal Drug Compounding Debate
11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions
Communicating Emerging Drug Therapies Prior to FDA Approval
Digital Health Technologies: A New FDA Regulatory Paradigm
Biologics Across the Globe: New Regulatory Challenges and Opportunities
Patient-Centric Perspectives: Models for Patient Engagement
Criminal Prosecutions Under the Food, Drug & Cosmetic Act
12:30–2:00 PM: Luncheon
FDLI Distinguished Service and Leadership Awards
Award Recipients:
Keynote Speaker
2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions
Legal Limits on Pharmacy Adherence and Discount Programs
Emerging Issues and Trends in Biologics Compliance and Enforcement
Veterinary Products and FTC Enforcement
4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception
Friday, May 5
7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome
Service to FDLI Award
FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization
10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions
Challenges and Opportunities in Combination Medical Product Regulation
FDA’s Implementation of the 21st Century Cures Act
Regulation of Cannabis in FDA-Regulated Products
Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions
FDA’s User Fee Program Reauthorization Update
Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
Defending Your Product: Crisis Management, Recalls, and Strategy
Economic Considerations for Biosimilar Litigation
2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment
Wednesday, May 3
5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel
Thursday, May 4
7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome
8:45–9:15 AM: FDA Keynote Address
9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration
10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions
Tobacco Product Standards for Combustible Products: Nicotine and Beyond
11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions
Criminal Prosecutions Under the Food, Drug & Cosmetic Act
12:30–2:00 PM: Luncheon
FDLI Distinguished Service and Leadership Awards
Award Recipients:
Keynote Speaker
2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors
Center for Tobacco Products (CTP)
3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions
Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve
4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception
Friday, May 5
7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome
Service to FDLI Award
FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization
10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions
CTP’s Compliance and Enforcement Initiatives Post-Deeming
12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions
Defending Your Product: Crisis Management, Recalls, and Strategy
2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment
Register By March 31 and SAVE!
Industry & Firms
- +$400 for nonmembers
- +$100 after 3/31/17
Non-Profit
- +$100 for nonmembers
- +$100 after 3/31/2017
Government
- +$100 for nonmembers
- +$100 after 3/31/2017
Academic
- +$100 for nonmembers
- +$100 after 3/31/2017
Student
- +$100 for nonmembers
- +must provide transcripts
Bring the Experts Back to Your Office
Make more of your conference experience by adding online access to the synced audio and speaker slides for the keynote and plenary sessions to your registration for just $99 for members or $199 for nonmembers. Select the “optional function” to take advantage of this offer. You will be notified how to access the video after the conference.
Do You Qualify for a Complimentary or Discounted Registration?
- Member manufacturers, suppliers and distributors with more than $1 billion in sales as well as member law firms get one complimentary registration as part of their annual membership dues.
- Member manufacturers, suppliers and distributors with less than $1 billion in sales get one registration at 50% off as part of their annual membership dues.
- Organizational members are also eligible for a group registration discount. Pay for four attendees and the fifth is complimentary.
To take advantage of these opportunities, please contact the Membership Department. For other Annual Conference questions, please contact Customer Service.
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Exhibitor
Planning Committee
Co-Chairs
Dave Ceryak Senior Director – Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Leslie T. Krasny Partner, Keller and Heckman LLP
Planning Committee
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville and American Heart Association
Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.
Neil DiSpirito, Of Counsel, Ballard Spahr LLP
Joy Liu, Vice President, Commercial and Regulatory Legal, Vertex Pharmaceuticals
Jeff Nelligan, Communications for the Deputy Commissioner for Global Regulatory Operations and Policy, FDA
May Nelson, Deputy Director, Office of Regulations, Center for Tobacco Products, Office of Medical Products and Tobacco, FDA
Jeannie Perron, Partner, Covington & Burling, LLP
Kim Tyrrell-Knott, Member of the Firm, Epstein Becker & Green
Continuing Legal Education
FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.
Call for Proposals
The Planning Committee thanks all who participated in the Call for Proposals that took place this past Fall. The broad input on topics from our members has helped us to put together a tremendous program.
Location and Overnight Accommodations
Conference Location
Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue NW Washington, DC 20004
Overnight Accommodations
Rooms are available at a discounted rate of $309 a night through April 11, 2017 at the JW Marriott Hotel. After that date, rates and availability may vary. Make Reservation Business attire is recommended and some meeting rooms may have cooler temperatures. Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.